Abstral Approval History
FDA Approved: Yes (First approved January 7, 2011)
Brand name: Abstral
Generic name: fentanyl
Dosage form: Sublingual Tablets
Company: Orexo AB
Treatment for: Pain
Abstral (fentanyl) is a sublingual opioid analgesic indicated for the management of breakthrough pain in cancer patients.
Development History and FDA Approval Process for Abstral
|Jan 10, 2011||FDA Approval for Abstral (Fentanyl) Sublingual Tablets|
|Sep 7, 2010||Update on the FDA review for Abstral|
|Jun 15, 2010||Orexo confirms Abstral PDUFA date update|
|Oct 6, 2009||Orexo confirms FDA acceptance of Abstral filing|
|Aug 6, 2009||Abstral NDA submitted to the FDA for approval in the USA|
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